US11135404B2 - Safety catheter needle - Google Patents

Safety catheter needle Download PDF

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Publication number
US11135404B2
US11135404B2 US16/771,037 US201816771037A US11135404B2 US 11135404 B2 US11135404 B2 US 11135404B2 US 201816771037 A US201816771037 A US 201816771037A US 11135404 B2 US11135404 B2 US 11135404B2
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United States
Prior art keywords
cannula
catheter
holder
safety
movable body
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US16/771,037
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US20210187249A1 (en
Inventor
Matteo Lagana′
Dario DE ZOLT
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Sol Millennium Swiss R&D Center SA
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Sol Millennium Swiss R&D Center SA
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Assigned to SOL-MILLENNIUM SWISS R&D CENTER SA reassignment SOL-MILLENNIUM SWISS R&D CENTER SA ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: DE ZOLT, DARIO, LAGANA', Matteo
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • A61M25/0618—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for protecting only the distal tip of the needle, e.g. a needle guard
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0222—Materials for reducing friction

Definitions

  • the present invention relates to a safety catheter needle according to the precharacterising clause of the principal claim.
  • a catheter needle or merely “catheter” is a medical device which enables a catheter of plastics material to be inserted into the peripheral venous system of a patient or into a vein of the latter or into the subcutaneous adipose tissue of the patient in order to be able to administer or extract liquids to or from the latter's body.
  • a metal cannula with a cutting end projecting from the catheter
  • inserted within the catheter itself which has the function of inserting the latter into for example a vein of the patient and which is removed by a health professional who performs this insertion operation at the end of the catheter positioning procedure.
  • Known safety catheters have incorporated safety devices having different functions and configurations. Some of these, for example, only protect the tip of the cannula once the latter has been drawn out from the catheter, this protection being obtained by enveloping the tip of the cannula in bodies associated with the catheter.
  • Devices capable of protecting both the tip and the surface of the cannula by means of telescopic systems or sliding shells activated manually by the health professional after the cannula has been drawn out from the catheter are in particular known; such are for example described in U.S. Pat. Nos. 4,747,831 and 6,436,070. These devices are referred to as safety catheters of the active type.
  • the systems for enveloping only the tip after the cannula has been drawn out from the catheter may be either housed within a catheter holder or outside it. When removed outside the catheter holder the systems protecting only the tip often have lateral or frontal openings such that in principle they do not prevent small drops of patients' body fluid from emerging, and this might give rise to problems for the health professional.
  • Safety catheters provided with devices capable of preventing a health professional from coming into contact with the tip of the cannula after it has been drawn out from the catheter and operating through a moving rotating element between the catheter holder which houses the aforesaid tip after it has been drawn out from the catheter are known.
  • EP2211942 describes a protection system associated with the catheter holder and comprising a moving element which through rotation in a chamber of the catheter holder (or an adapter associated therewith) is capable of receiving the tip of the cannula before the latter projects from the catheter holder itself. Rotation takes place because of the interference between a bevel in the cannula close to its tip and said moving element during the stage in which the cannula is removed from the catheter holder.
  • the moving element should be of such a shape as to ensure that it couples with the tip of the cannula and this makes it necessary to manufacture the parts (at least the moving element) with very small construction tolerances, which is in itself very difficult. Small offsets between the catheter holder and the moving element or even small variations in construction may result in incorrect movement of the moving element with consequent malfunction of the protection device described in the prior document.
  • this moving element does not ensure that body fluids (for example blood) associated with the cannula are contained, with the consequent possibility that they may be lost, with obvious hazards and disadvantages for both any health professionals and persons who might come into contact with it.
  • body fluids for example blood
  • These devices have protection members provided with a rotating element or part capable of being located in front of the tip of the cannula after this has entered such protection component.
  • WO 00/06226 describes a different safety device capable of preventing contact with the tip of a catheter after use.
  • the object of the present invention is to provide a safety catheter needle (or merely “safety catheter”) of the above-mentioned type which is improved in comparison with similar known solutions.
  • the object of the present invention is that of providing a catheter of the type mentioned which offers improved safety not only with respect to the fact that the tip of the cannula cannot come into contact with a health professional, but also in that there is a small possibility that body fluids may emerge from the protective element and come into contact with the health professional.
  • Another object of the present invention is that of providing a safety catheter of the type mentioned which operates in wholly passive mode or without the health professional having to act in order to achieve protection of the tip of the cannula by acting on the latter or on members associated with it.
  • Another object is that of providing a safety catheter of the type mentioned in which the tip of the cannula is absolutely inaccessible to an operator after it has been drawn out from the catheter holder.
  • Another object is to provide a safety catheter of the above-mentioned type which does not lose its protection characteristics over time, said characteristics remaining unchanged even after different periods of time after production of the catheter.
  • Another object is that of providing a safety catheter which has a small number of components and is simple to manufacture and assemble, such as to have high reliability in use and low cost.
  • FIG. 1 shows a perspective view of a safety catheter according to the present invention
  • FIG. 2 shows a cross-section along the line 2 - 2 in FIG. 1 ;
  • FIG. 3 shows an exploded perspective view of the catheter in FIG. 1 in which all the components of the safety catheter are shown;
  • FIGS. 4 a -4 d show cross-sectional views of a safety catheter according to the invention ( FIG. 4 a ) and various stages in the extraction of a cannula from a catheter holder, with the intervention of a protection device according to one embodiment of the invention;
  • FIGS. 5 a and 5 b show assembled perspective views of the protection device in FIG. 4 during different stages of use
  • FIGS. 6 a and 6 b show perspective views of the individual components of the protection device in FIG. 4 ;
  • FIGS. 7 a -7 b show a perspective view and a longitudinal cross-section respectively of a variant of a first component of the device in FIG. 4 ;
  • FIGS. 8 a and 8 b show a perspective view and a longitudinal perspective cross-section respectively of a variant of a second component of the device in FIG. 4 ;
  • FIG. 9 shows a perspective view of another variant of the second component of the device in FIG. 4 ;
  • FIGS. 10 a and 10 b show perspective views, in exploded view and before and after completion respectively, of a variant of the first component of the device in FIG. 4 ;
  • FIG. 11 shows a perspective view of a variant of a safety catheter according to the invention.
  • FIG. 12 shows a cross-section along the line 12 - 12 in FIG. 11 , with part of the catheter not shown for greater clarity;
  • FIG. 13 shows a perspective exploded view of a detail of a catheter holder according to a variant of the invention shown in FIG. 11 ;
  • FIG. 14 shows the catheter holder in FIG. 13 in exploded perspective view and longitudinal cross-section
  • FIGS. 15 a , 15 b , 15 c show portions of the catheter in FIG. 11 during different stages of use.
  • FIGS. 1-10 show a safety catheter needle (or “safety catheter”) according to the invention; the safety catheter is indicated as a whole by reference number 1 .
  • This safety catheter comprises as a whole (see FIGS. 1-3 ), a protection element or protector 2 which when associated with safety catheter 1 is made of one piece in a known way with catheter holder 3 which in turn is removably attached to a cannula holder 4 .
  • the cannula holder comprises a normal chamber for the backflow of body fluid (for example blood);
  • a safety device 8 is associated with catheter holder 3 and is capable of containing a tip 10 of a cannula 11 after the latter has been drawn out from the catheter holder after catheter 1 has been used.
  • Cannula holder 4 is also preferably associated with a normal ventilation connection having a hydrophobic filter 15 (or other equivalent system which is in itself known) and a Luer Lock cap 16 , which is in itself known.
  • Cannula 11 has a variation in cross-section, for example a bevel 11 C close to its tip or distal extremity 10 .
  • the proximal extremity 20 of cannula 11 is internally fixed to cannula holder 4 .
  • proximal and distal are used in relation to the positions of cannula 11 with respect to cannula holder 4 or, better, Luer lock cap 16 (or extremity 1 A of safety catheter 1 opposite extremity 1 B where tip 10 of cannula 11 is present); every further mention of “proximal” or “distal”, including with reference to other components of safety catheter 1 , will relate to the latter.
  • Metal cannula 11 has a distal extremity or tip of cannula 10 constructed, for example by means of a cut on an inclined plane with respect to the longitudinal axis W of the cannula (and the entire safety cannula 1 ), so that it is cutting.
  • This cannula 11 is capable of permitting a catheter 14 to be inserted into a vein, an artery or the adipose tissue of a patient, an operation normally performed by a health professional.
  • catheter 14 has a longitudinal through hole 14 K; the distal extremity or tip 10 of cannula 11 projects from a distal extremity 14 A of catheter 14 before and during the aforesaid operation.
  • Catheter 14 has a proximal extremity 14 B which in a known way is of one piece with catheter-immobilising insert 13 .
  • the catheter holder comprises protection and safety device 8 which is capable of receiving and retaining within it the distal extremity or tip 10 of cannula 11 after catheter 14 has been inserted into the body of a patient and this cannula has been drawn out from the catheter itself.
  • safety device 8 is of the passive type and comprises a containment body 23 (or “first body” or “principal body”) having a through longitudinal cavity 23 A (located along the W axis) with a proximal opening or hole 24 in a proximal portion 28 of body 23 and a distal opening 25 in a distal portion 29 of the body itself (which also represents the distal extremity of protection device 8 ).
  • Hole or opening 24 has dimensions which are smaller than the dimensions of bevel 11 C (and will also be described below as a small hole 24 ).
  • Containment body 23 can contain the distal extremity or tip 10 of cannula 11 after said cannula has been drawn out from catheter 14 in order to protect a health professional who has performed the aforesaid extraction operation.
  • At distal extremity 25 containment body has a cavity 30 which is open on three sides ( 30 A, 30 B, 30 C) adjacent to arms 31 and 32 having three ends 33 facing distal opening 25 that are resiliently drawn together.
  • These arms 31 and 32 bound a channel 34 capable of receiving an eccentric lateral projection 35 of a moving body 37 (or second body of device 8 ) substantially of a barrel or cylindrical shape held in such a way that it can rotate within above-mentioned cavity 30 .
  • rotating moving body 37 (which is cylindrical or in any event of a shape approximating to a solid of revolution) has a longitudinal axis and rotation axis M located at right angles to axis W and can rotate within cavity 30 when eccentric lateral projection 35 experiences a force directed along the W axis in the direction of distal extremity 29 of containment body 23 (as will be described below).
  • Arms 31 and 32 which are located next to distal portion 29 , have projections 38 facing each other on which is supported lateral projection 35 of rotating moving body 37 when the latter is in the first working position in which cannula 4 passes through it.
  • Rotating movable body 37 in fact has a through hole 40 , having an axis Z at right angles to the M axis (and therefore capable of overlapping the W axis), and this hole 40 is capable of containing cannula 11 in passing mode when the latter is within catheter 14 or is outside protection device 8 .
  • hole 40 has an axis Z substantially coinciding with above-mentioned W axis and specifically contains said catheter with through cavity 23 A of principal body 23 . This hole 40 is thus coaxial with cavity 23 A in body 23 .
  • the terms “substantially coinciding with” or “substantially capable of being overlapped with” mean that the Z axis may be precisely overlapped with and coincide with the W axis, but also that this Z axis may be slightly inclined with respect to the W axis. This may for example arise because of the fact that the rotating movable body is slightly rotated within cavity 30 and the edge of hole 40 bears against cannula 11 when this cannula is inserted in said hole.
  • body 23 or first body of protection and safety device 8 has a fin or projection 42 which when the safety catheter is in use (or catheter 14 is inserted into the patient) is capable of acting together with a wall 43 of a cavity 44 within cannula holder 4 to ensure correct alignment with such cannula holder.
  • projection 42 bears on a proximal extremity 3 A of catheter holder 3 (see FIGS. 2, 4 a and 4 b ) and acts as an immobilising agent to prevent device 8 from being excessively inserted within such cannula holder, with a corresponding increase in the extraction force, when safety catheter 1 is being assembled.
  • both translational and rotational alignment with cannula holder 4 is essential for correctly positioning tip 10 of cannula 11 with respect to a normal taper which is provided on catheter and to orientate the sharp part of the aforesaid cannula tip in such a way that the apex of the tip faces the surface of the injection site.
  • Catheter holder 3 has internally an enlarged part 46 which when the safety catheter is in the position of use and catheter 14 and cannula 11 are inserted into a patient is capable of containing lateral projection 35 of rotating moving body or second body 37 of device 8 (see FIGS. 4 a and 4 b ).
  • This enlarged part 46 has a proximal step 46 A capable of interacting or acting directly together with projection 35 of body 37 when cannula 11 is drawn out from catheter 14 . Following this interaction body 37 rotates in cavity 30 and this projection moves between arms 31 and 32 into channel 34 towards distal extremity 29 A of distal portion 29 of body 23 .
  • Hole 40 of rotating moving body 37 is free from the cannula, while tip 10 thereof, which has been drawn out from the catheter, is wholly within cavity or hole 23 A.
  • Arms 31 , 32 and their resiliently movable projections 38 prevent reversal of the rotation of cylindrical body 37 and thus constitute an obstacle to realignment between hole 40 and cavity 23 A for the passage of cannula 11 preventing tip 10 of the cannula from being exposed from safety device 8 through distal extremity 29 of device 8 .
  • This device is made of plastics material (preferably self-lubricating low-friction plastics) having sufficient strength not to be deformed or altered by tip 10 of the cannula and therefore capable of preventing it from emerging, even in the event of accidental impact.
  • plastics material preferably self-lubricating low-friction plastics
  • the (calibrated) hole 24 in cavity 23 A present in principal body 23 of the safety device can advantageously be reinforced by a metal annular element or ring 49 which is co-moulded and assembled therewith (see FIGS. 15 a - c ).
  • This metal ring ensures greater interference between bevel 11 C of cannula 11 and calibrated hole 24 so as to prevent tip 10 of the cannula from emerging therefrom.
  • projection 35 which causes such cylindrical body to rotate by acting together with step 46 A of the catheter holder is of an increased length in comparison with that of the solution in the figures above such as to cause greater angular rotation and ensure greater safety in the action of device 8 .
  • the angle of rotation of rotating cylindrical body 37 is further increased through a projection 35 in the shape of an upside-down L comprising horizontal portion 51 and a vertical portion 52 ; this solution further delays the moment when such projection 35 engages step 46 A.
  • principal body 23 of safety device 8 is made as a cylindrical member in which cavity 30 for rotating body 37 opens on only one side 30 B in such principal body (and, obviously, towards channel 34 ); this solution enables said rotating cylindrical body 37 to be inserted into cavity 30 from that side so that it is immobilised therein, while allowing it to rotate (see FIGS. 7 a and 7 b ).
  • principal body 23 is made of metal or from a metal sheet. This ensures correct interference between hole 24 of through cavity 23 and bevel 11 C in cannula 11 without having to resort to an additional metal immobilising ring (with consequent advantages during the assembly stage and a smaller number of components).
  • one possible way of obtaining safety device 8 comprises starting from a tubular metal structure, closed by an end member in which there is made (calibrated) hole or opening 24 capable of interfering with bevel 11 C and bringing about successive resilient deformations 56 and 57 (deformation 57 corresponding to distal portion 29 ) so as to lock translation movement of cylindrical body 37 along the W axis without blocking its rotation.
  • This body 37 is inserted axially into body 23 from distal portion shaped, before it undergoes resilient deformation ( 57 ), in the form of a cylindrical tube (see FIG. 10 a ).
  • Final resilient deformation 57 immobilises such cylindrical rotating body 37 within cavity 30 created between deformations 56 and 57 ( FIG. 10 b ).
  • catheter holder 3 comprises two components 70 and 71 assembled together by means of an interference fit (or by other suitably equivalent means of the ultrasound welding or adhesive bonding type). This makes it possible to obtain a marked step 46 A between said components (see FIGS. 15 a and 15 b ) through which a greater angle of rotation of cylindrical body 37 can be obtained when cannula 11 is separated from catheter 14 . This step is defined by the free extremity 71 A of component 71 .
  • Components 70 and 71 are joined together by the (snap) insertion of a collar 73 of component 71 into an annular recess 74 in component 70 .
  • these components may be joined together using other known means, such as adhesive bonding or ultrasound welding.
  • component 71 (the proximal component of catheter holder 3 attached to distal component 70 ) may have a recess 80 on an annular flanged edge 81 capable of orientating safety device 8 in an optimum way with respect to catheter holder 3 so that tip 10 of the cannula is in the correct position as described above.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
US16/771,037 2017-12-18 2018-12-12 Safety catheter needle Active US11135404B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IT201700145675 2017-12-18
IT102017000145675 2017-12-18
PCT/IB2018/059932 WO2019123120A1 (fr) 2017-12-18 2018-12-12 Aiguille de cathéter de sécurité perfectionnée

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US20210187249A1 US20210187249A1 (en) 2021-06-24
US11135404B2 true US11135404B2 (en) 2021-10-05

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US16/771,037 Active US11135404B2 (en) 2017-12-18 2018-12-12 Safety catheter needle

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US (1) US11135404B2 (fr)
EP (1) EP3727552B1 (fr)
CA (1) CA3085536A1 (fr)
ES (1) ES2932661T3 (fr)
MA (1) MA51281A (fr)
WO (1) WO2019123120A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112057723A (zh) * 2020-09-17 2020-12-11 关凤良 一种安全导管针

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5300045A (en) * 1993-04-14 1994-04-05 Plassche Jr Walter M Interventional needle having an automatically capping stylet
WO2000006226A1 (fr) 1998-07-31 2000-02-10 Albany Medical College Ensemble catheter intraveineux de securite et utilisation avec une aiguille
US20080065015A1 (en) 2004-11-01 2008-03-13 Richard Fiser Locking clip with trigger bushing
EP1920796A1 (fr) 2006-11-07 2008-05-14 ARTSANA S.p.A. Aiguille de canule de sécurité dotée d'un élément de protection d'aiguille automatiquement activé lors de la séparation de l'aiguille du cathéter
WO2012016660A1 (fr) 2010-08-05 2012-02-09 B. Braun Melsungen Ag Dispositif et ensemble de protection d'aiguille

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5300045A (en) * 1993-04-14 1994-04-05 Plassche Jr Walter M Interventional needle having an automatically capping stylet
WO2000006226A1 (fr) 1998-07-31 2000-02-10 Albany Medical College Ensemble catheter intraveineux de securite et utilisation avec une aiguille
US20080065015A1 (en) 2004-11-01 2008-03-13 Richard Fiser Locking clip with trigger bushing
EP1920796A1 (fr) 2006-11-07 2008-05-14 ARTSANA S.p.A. Aiguille de canule de sécurité dotée d'un élément de protection d'aiguille automatiquement activé lors de la séparation de l'aiguille du cathéter
WO2012016660A1 (fr) 2010-08-05 2012-02-09 B. Braun Melsungen Ag Dispositif et ensemble de protection d'aiguille

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
International Search Report and Written Opinion for Corresponding International Application No. PCT/IB2018/059932 (9 Pages) (dated Mar. 21, 2019).

Also Published As

Publication number Publication date
WO2019123120A1 (fr) 2019-06-27
EP3727552A1 (fr) 2020-10-28
EP3727552B1 (fr) 2022-10-05
US20210187249A1 (en) 2021-06-24
CA3085536A1 (fr) 2019-06-27
ES2932661T3 (es) 2023-01-23
MA51281A (fr) 2021-03-24

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